1. Field of the Invention
The present invention relates generally to treatment protocols. More particularly, embodiments of the present invention relate to systems, devices, methods, and software for use in the creation, implementation, use and/or refinement of treatment protocols.
2. Related Technology
Young infants are particularly susceptible to a wide variety of infections, diseases and conditions. While some of these infections, diseases and conditions may be relatively benign, others can pose a significant threat to the health and well being of the infant. Bacterial infections, for example, are of particular concern because they can cause potentially life-threatening fever in very young infants. Accordingly, even though the risk of occurrence of a bacterial infection, for example, may be relatively low, typical treatment protocols tend to favor admission of the infant to the hospital for treatment of the infection with an aggressive antibiotic therapy. While, as discussed below, such treatment can be problematic, the treating physician, generally not a pediatric specialist, often tends to view any disadvantages as being acceptable in light of the potential risk to the life of the child if a less aggressive approach to treatment is taken.
As suggested above, protocols have been developed concerning the treatment of febrile infants. One commonly employed treatment protocol is sometimes referred to as the ‘Rochester criteria.’ The Rochester criteria were developed in 1985 with a view towards classifying infants with fever, according to the risk that such infants had a bacteria-induced fever. As disclosed elsewhere herein, the Rochester criteria are generally concerned with: (i) selected aspects of the medical history of the infant; (ii) results of a physical examination of the infant; and (iii) a laboratory evaluation of, for example, the urine and blood of the infant.
Application of the Rochester criteria to a particular infant produces a risk profile for the infant. Once classified according to level of risk, the infants could be treated accordingly. By way of example, if an infant satisfactorily fulfills all of the Rochester criteria, that infant would be classified as being at ‘low risk’ for contracting a serious bacterial infection (“SBI”). On the other hand, if an infant were under ninety (90) days of age, had a fever of 38° C. or higher, and missed any one of the fifteen (15) Rochester criteria, that infant would likely be classified as being ‘high risk,’ with a risk of having a serious bacterial infection of about twenty one percent (21%). Infants falling into the ‘high risk’ category are generally admitted to the hospital and treated as described above. Such admission and treatment is sometimes referred to as a ‘rule out sepsis’ (“ROS”) evaluation.
Notwithstanding the benefits that may be realized by the ‘fail safe’ approach implicated by the Rochester criteria and similar protocols, this type of approach to treatment of the young febrile infant has proven to be problematic. By way of example, parents can become traumatized when informed that an ROS evaluation is required because their child may have a life-threatening illness. In this regard, there is often a significant, adverse psychological effect on the parent, sometimes referred to as ‘the vulnerable child syndrome,’ where parents tend to treat such infants differently is because it is the perception of the parents that the child is weak or sickly. Moreover, a stay in the hospital is traumatic for the infant as well as for the parents. By way of example, trauma to the infant may occur when breast feeding of the infant is interrupted for the performance of various procedures or the administration of drugs or antibiotics. Further, infections and other complications may also occur as a result of hospitalization of the infant.
Not only does the use of the Rochester criteria, and similar approaches, implicate various concerns for both the parent and the infant with respect to the ROS evaluation, but questions now exist as to the usefulness of the Rochester criteria, at least when it is employed as the sole basis for admission and ROS evaluation decisions. By way of example, more recent studies have shown that a febrile infant less than ninety (90) days old with a 38° C. degree temperature, that misses one of the Rochester criteria, has a risk of having a bacterial infection of only about nine percent (9%), in contrast with the twenty one percent (21%) figure reported when the Rochester criteria were initially developed. Thus, the ability of the Rochester criteria to accurately predict bacterial infections and, thus, the usefulness of the Rochester criteria, has diminished considerably over time.
The diminished utility of the Rochester criteria is due in part to the occurrence of various changes that have influenced the epidemiology of bacterial infection in infants. Examples of such changes include: (i) universal immunization against Haemophilus influenzae; routine screening and intrapartum antibiotic prophylaxis for the prevention of group B Streptococcus infection; and (iii) the introduction of immunization against Streptococcus pneumoniae. Thus, while such changes have dramatically reduced the incidence of disease due to these pathogens, little or no reassessment has been made of the risk of bacterial infection in the febrile infant. Not only has the usefulness of the Rochester criteria diminished with the passage of time, but the underlying approach exemplified by the Rochester criteria is cause for concern as well. In particular, the Rochester criteria and other similar schemes are designed to identify only those infants at risk for bacterial infection However, studies have shown that only about eight infants out of a hundred typically contract a bacterial infection. Moreover, some studies have shown that while fever in young infants does occur as a result of bacterial pathogens, it is much more likely that a fever in a young infant is due to a benign viral illness. Treatment of a viral illness with antibiotics, such as would be dictated by the Rochester criteria, is thus ineffective, time-consuming and expensive.
Although a significant majority of fevers in young infants are due to viral pathogens, the use of treatment protocols such as those implicated by the Rochester criteria nonetheless persist. The rationale for the persistence of the use of such treatment protocols relates, at least in part, to the identification of viral and bacterial pathogens in young infants.
By way of example, there is presently no known reliable method for rapidly and reliably detecting and identifying bacterial infections in young infants. Moreover, only limited information has been available concerning testing for viral pathogens, and the management of infants with viral infections. In light of the foregoing, it is generally considered a prudent course of action to presume that any fever presented in a young infant is due to bacterial pathogens, and to admit the infant for treatment with a corresponding course of antibiotics.
As suggested by the foregoing, the Rochester criteria and similar treatment protocols tend to result in the over-prescription of antibiotics for febrile infants, notwithstanding that a significant majority of the fevers presented in young infants are a result of benign viral illness. Such a result is problematic because over-prescription of antibiotics, also referred to as ‘antimicrobials,’ is a factor that contributes to increased antimicrobial resistance among bacterial pathogens such as are commonly encountered in pediatrics. This increase in antimicrobial resistance tends to diminish the effectiveness of many known antibiotics in treating fevers and other conditions that result from bacterial pathogens. Additionally, certain antimicrobials contribute to secondary diseases directly caused by the agents themselves.
In view of the foregoing problems, and other problems in the art not specifically enumerated herein, what is needed are systems, devices, methods, and software for use in the creation, implementation, use and/or refinement of various treatment protocols. Implementations of the systems, methods and/or software should be configured for use in connection with a variety of different types of computing environments.
Among other things, such systems, devices, methods, and software should identify relationships implicit or explicit in bodies of patient data, and should advantageously implement such relationships, either alone or in connection with established protocols, in the form of rule-based treatment protocols that permit rapid and accurate assessments of, for example, the risk of serious pathologic infection in a patient. At least some of such protocols should be based at least in part upon information and data concerning both bacterial and viral epidemiology and testing.
Furthermore, the systems, devices, methods, and software should permit periodic reassessment of data in order to facilitate refinement of existing treatment protocols and/or the development of new treatment protocols. Finally, the systems, methods and software should be configured to operate in various modes, including a real time mode, and should implement various management functionalities such as the definition and printing of various types of reports.